FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
43353-072
11-digit product format
433530072
Labeler code
43353
Product ID
43353-072_5e1836c1-7b36-4ea5-8fa2-87e8d8d6b21f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-072-152020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-202020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-242020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-282020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-302020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-402020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-452020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-462020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-482020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-502020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-532020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-542020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-572020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-602020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-652020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-672020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-702020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-722020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-732020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-752020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-802020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-852020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-892020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-902020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-922020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-942020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only
43353-072-982020-01-31C16284748780-19d75b9d0-470e-f424-e053-dadaa90a57ceTramadol Hydrochloride Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-072-15Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, COATED154
43353-072-20Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, COATED204
43353-072-24Tramadol Hydrochloride224 in 1 BOTTLE, PLASTICTABLET, COATED2244
43353-072-28Tramadol Hydrochloride28 in 1 BOTTLE, PLASTICTABLET, COATED284
43353-072-30Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED304
43353-072-40Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, COATED404
43353-072-45Tramadol Hydrochloride45 in 1 BOTTLE, PLASTICTABLET, COATED454
43353-072-46Tramadol Hydrochloride56 in 1 BOTTLE, PLASTICTABLET, COATED564
43353-072-48Tramadol Hydrochloride480 in 1 BOTTLE, PLASTICTABLET, COATED4804
43353-072-50Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET, COATED504
43353-072-53Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, COATED604
43353-072-54Tramadol Hydrochloride84 in 1 BOTTLE, PLASTICTABLET, COATED844
43353-072-57Tramadol Hydrochloride80 in 1 BOTTLE, PLASTICTABLET, COATED804
43353-072-60Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED904
43353-072-65Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, COATED1004
43353-072-67Tramadol Hydrochloride168 in 1 BOTTLE, PLASTICTABLET, COATED1684
43353-072-70Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, COATED1204
43353-072-72Tramadol Hydrochloride112 in 1 BOTTLE, PLASTICTABLET, COATED1124
43353-072-73Tramadol Hydrochloride135 in 1 BOTTLE, PLASTICTABLET, COATED1354
43353-072-75Tramadol Hydrochloride150 in 1 BOTTLE, PLASTICTABLET, COATED1504
43353-072-80Tramadol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, COATED1804
43353-072-85Tramadol Hydrochloride200 in 1 BOTTLE, PLASTICTABLET, COATED2004
43353-072-89Tramadol Hydrochloride720 in 1 BOTTLE, PLASTICTABLET, COATED7204
43353-072-90Tramadol Hydrochloride240 in 1 BOTTLE, PLASTICTABLET, COATED2404
43353-072-92Tramadol Hydrochloride270 in 1 BOTTLE, PLASTICTABLET, COATED2704
43353-072-94Tramadol Hydrochloride360 in 1 BOTTLE, PLASTICTABLET, COATED3604
43353-072-98Tramadol Hydrochloride540 in 1 BOTTLE, PLASTICTABLET, COATED5404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-072-15EA - Each43353-072bfcee61a-1698-42b7-83b5-99bc01f6d20312015-05-05
43353-072-20EA - Each43353-07260696c93-9500-42a0-aee7-f61d40b7276b12015-05-05
43353-072-24EA - Each43353-072eb595ad9-a542-4e82-99e1-86e59003738012015-01-05
43353-072-28EA - Each43353-07297c09f1d-b50f-48f3-8a72-8a4f7add6d1b12015-05-05
43353-072-30EA - Each43353-072f5ec579d-e5a9-4dce-8b54-dabb2ffb436c12014-06-03
43353-072-40EA - Each43353-072981c0929-684b-48db-b235-7b86d9b52bcc12015-05-05
43353-072-45EA - Each43353-072fe05af89-b48c-4b98-8401-891257b62d8312014-06-03
43353-072-46EA - Each43353-07240b8b2df-97ab-4b52-b9aa-f2b8d7bc9e4812015-01-05
43353-072-50EA - Each43353-0725ef5ab30-20ad-4418-b041-e9ea382194f212015-05-05
43353-072-53EA - Each43353-0726c6f7abe-f511-4e47-8d4a-da45f232951412014-06-03
43353-072-54EA - Each43353-072cc93d9f5-011d-4b93-add4-4c410e22080312015-01-05
43353-072-57EA - Each43353-072e1ec1cf7-4418-4615-a0ac-bc5661d8a74f12015-05-05
43353-072-60EA - Each43353-072e29cca32-7e33-445c-8e41-b036a573f64112014-06-03
43353-072-65EA - Each43353-072440ef3f6-63f1-496f-931c-df779c6f6a0d12015-05-05
43353-072-67EA - Each43353-0728e7eec68-8956-4e1a-a73d-e87b116936d512015-01-05
43353-072-70EA - Each43353-0727a0eb9e5-03c1-4895-846b-3b8f712a5e5c12014-06-03
43353-072-72EA - Each43353-072610ab23a-4d33-4e23-aa3d-24442f669dd212015-01-05
43353-072-73EA - Each43353-0729b51d5a4-1089-42df-90d0-bddd841560c512015-05-05
43353-072-75EA - Each43353-072e1dc8b3a-d568-4566-9068-8fc21d9f7bd612014-06-03
43353-072-80EA - Each43353-072ee5c57cc-9593-4795-a3bd-bcc8e93c6d7c12014-06-03
43353-072-85EA - Each43353-072d5d838a8-f721-469b-99b9-50c902ef933012015-05-05
43353-072-89EA - Each43353-0722d1d4f9c-83e9-48d2-b660-784ecf70062212015-05-05
43353-072-90EA - Each43353-072625b0da4-7f9d-481e-97b0-67752cb454ca12014-06-03
43353-072-92EA - Each43353-0727c3c7551-5add-454f-942e-5817bffbb8a312014-06-03
43353-072-94EA - Each43353-0727cd19ee0-08dc-42e9-9c2f-7a12a9e6977412014-06-03
43353-072-98EA - Each43353-0721bcb93ee-5f66-4782-b252-86604dd5af6512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-072TRAMADOL HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 27 package rows20140718_648d4e25-d72d-4434-b5fe-119b6c586afe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN648d4e25-d72d-4434-b5fe-119b6c586afe4
835603tramadol hydrochloride 50 MG Oral TabletSCD648d4e25-d72d-4434-b5fe-119b6c586afe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-072-154335300721515 in 1 BOTTLE, PLASTICHistorical
43353-072-204335300722020 in 1 BOTTLE, PLASTICHistorical
43353-072-2443353007224224 in 1 BOTTLE, PLASTICHistorical
43353-072-284335300722828 in 1 BOTTLE, PLASTICHistorical
43353-072-304335300723030 in 1 BOTTLE, PLASTICHistorical
43353-072-404335300724040 in 1 BOTTLE, PLASTICHistorical
43353-072-454335300724545 in 1 BOTTLE, PLASTICHistorical
43353-072-464335300724656 in 1 BOTTLE, PLASTICHistorical
43353-072-4843353007248480 in 1 BOTTLE, PLASTICHistorical
43353-072-504335300725050 in 1 BOTTLE, PLASTICHistorical
43353-072-534335300725360 in 1 BOTTLE, PLASTICHistorical
43353-072-544335300725484 in 1 BOTTLE, PLASTICHistorical
43353-072-574335300725780 in 1 BOTTLE, PLASTICHistorical
43353-072-604335300726090 in 1 BOTTLE, PLASTICHistorical
43353-072-6543353007265100 in 1 BOTTLE, PLASTICHistorical
43353-072-6743353007267168 in 1 BOTTLE, PLASTICHistorical
43353-072-7043353007270120 in 1 BOTTLE, PLASTICHistorical
43353-072-7243353007272112 in 1 BOTTLE, PLASTICHistorical
43353-072-7343353007273135 in 1 BOTTLE, PLASTICHistorical
43353-072-7543353007275150 in 1 BOTTLE, PLASTICHistorical
43353-072-8043353007280180 in 1 BOTTLE, PLASTICHistorical
43353-072-8543353007285200 in 1 BOTTLE, PLASTICHistorical
43353-072-8943353007289720 in 1 BOTTLE, PLASTICHistorical
43353-072-9043353007290240 in 1 BOTTLE, PLASTICHistorical
43353-072-9243353007292270 in 1 BOTTLE, PLASTICHistorical
43353-072-9443353007294360 in 1 BOTTLE, PLASTICHistorical
43353-072-9843353007298540 in 1 BOTTLE, PLASTICHistorical